The primary objective of this repository is to collect and store specimens from patients with suspicion of or diagnosed with bladder cancer. These specimens will be used to determine the local and systemic immune profiles of patients with bladder cancer.
The purpose of this study is to determine whether adding a year of everolimus to standard adjuvant hormonal therapy improves disease-free interval in patients with hormone-receptor-positive and HER2-negative breast cancer.
Eligible adult patients (either sex) have a diagnosis of breast cancer and have completed surgery, radiation therapy, and/or adjuvant or neoadjuvant chemotherapy and have no evidence of disease at time of study entry.
Patients with inflammatory breast cancer or metastatic disease, serious cardiac disease, uncontrolled diabetes, hepatitis, uncontrolled pulmonary disease, or impaired gastrointestinal function are not eligible.
Estimated Enrollment: 3500 patients from multiple cancer centers in the US.
The overarching goal for this protocol is to establish a National Clinical Trials Network (NCTN) mechanism for genomically screening large but homogeneous cancer populations and subsequently assigning and accruing simultaneously to a multi-sub study Master Protocol. Biomarker-driven sub-studies in this protocol will compare new targeted therapy (TT) or targeted therapy combinations (TTC) to standard of care (SoC) therapy based on designated therapeutic biomarker-drug combinations, with the ultimate goal being approval of new targeted therapies in this setting. In addition, the protocol includes a non-match sub-study which will include all screened patients not eligible for any of the biomarker-driven sub-studies. This sub-study will compare a non-match therapy (NMT) to SoC also with the goal of approval. We hypothesize that this Master Protocol mechanism will yield definable and measurable efficiencies in terms of improving genomic screening of cancer patients for clinical trial entry, and improved time lines for drug-biomarker testing allowing for inclusion of the maximum numbers of otherwise eligible patients in comparison with currently employed single screen-single trial approaches.
Objective: The purpose of this study is to compare the effects, good and/or bad, of using afatinib along with cetuximab to using afatinib alone in participants with non-small cell lung cancer which has an EGFR positive genetic mutation. The addition of cetuximab to the usual afatinib could shrink the cancer, but it could also cause side effects. The study will be considered positive if the study approach increases life by eight months or more compared to the usual approach.
a. To assess 2-year overall survival in each treatment arm (mFOLFIRINOX and gemcitabine/nab-paclitaxel) in patients with resectable pancreatic cancer.
b. If the stated threshold is met in one or both arms: to choose the better regimen with respect to 2-year overall survival.
To estimate, for all patients and within treatment arms:
a. Frequency and severity of adverse events associated with chemotherapy in the perioperative setting.
b. Proportion of patients going to surgery for resection after preoperative chemotherapy.
c. Proportion of patients achieving R0 resection after preoperative chemotherapy.
d. Overall response rate following preoperative chemotherapy, including confirmed and unconfirmed, complete and partial response, per RECIST 1.1.
e. Pathologic response rates after R0 or R1 resection.
f. Patterns of recurrence (loco-regional, distant) after R0 or R1 resection.
g. Disease-free survival from the time of R0 or R1 resection.